CA3037544C - Lyophilization methods that provide stably dehydrated protozoans for use as potent live vaccines - Google Patents

Lyophilization methods that provide stably dehydrated protozoans for use as potent live vaccines Download PDF

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Publication number
CA3037544C
CA3037544C CA3037544A CA3037544A CA3037544C CA 3037544 C CA3037544 C CA 3037544C CA 3037544 A CA3037544 A CA 3037544A CA 3037544 A CA3037544 A CA 3037544A CA 3037544 C CA3037544 C CA 3037544C
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Prior art keywords
chamber
holding
temperature
protozoa
minutes
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CA3037544A
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English (en)
French (fr)
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CA3037544A1 (en
Inventor
Rim Daoussi
Frederick H. Weber
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Zoetis Services LLC
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Zoetis Services LLC
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Publication of CA3037544A1 publication Critical patent/CA3037544A1/en
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/66—Microorganisms or materials therefrom
    • A61K35/68—Protozoa, e.g. flagella, amoebas, sporozoans, plasmodium or toxoplasma
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/002—Protozoa antigens
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1658—Proteins, e.g. albumin, gelatin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/76—Albumins
    • C07K14/765—Serum albumin, e.g. HSA
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N1/00—Microorganisms, e.g. protozoa; Compositions thereof; Processes of propagating, maintaining or preserving microorganisms or compositions thereof; Processes of preparing or isolating a composition containing a microorganism; Culture media therefor
    • C12N1/04—Preserving or maintaining viable microorganisms
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/51—Medicinal preparations containing antigens or antibodies comprising whole cells, viruses or DNA/RNA
    • A61K2039/52—Bacterial cells; Fungal cells; Protozoal cells
    • A61K2039/521—Bacterial cells; Fungal cells; Protozoal cells inactivated (killed)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/51—Medicinal preparations containing antigens or antibodies comprising whole cells, viruses or DNA/RNA
    • A61K2039/52—Bacterial cells; Fungal cells; Protozoal cells
    • A61K2039/522—Bacterial cells; Fungal cells; Protozoal cells avirulent or attenuated

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Organic Chemistry (AREA)
  • Genetics & Genomics (AREA)
  • Zoology (AREA)
  • Microbiology (AREA)
  • Biotechnology (AREA)
  • Tropical Medicine & Parasitology (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Wood Science & Technology (AREA)
  • Biochemistry (AREA)
  • Virology (AREA)
  • General Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Mycology (AREA)
  • Immunology (AREA)
  • Dermatology (AREA)
  • Toxicology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
CA3037544A 2016-10-05 2017-10-04 Lyophilization methods that provide stably dehydrated protozoans for use as potent live vaccines Active CA3037544C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201662404448P 2016-10-05 2016-10-05
US62/404,448 2016-10-05
PCT/US2017/055056 WO2018067647A1 (en) 2016-10-05 2017-10-04 Lyophilization methods that provide stably dehydrated protozoans for use as potent live vaccines

Publications (2)

Publication Number Publication Date
CA3037544A1 CA3037544A1 (en) 2018-04-12
CA3037544C true CA3037544C (en) 2021-10-12

Family

ID=60327367

Family Applications (1)

Application Number Title Priority Date Filing Date
CA3037544A Active CA3037544C (en) 2016-10-05 2017-10-04 Lyophilization methods that provide stably dehydrated protozoans for use as potent live vaccines

Country Status (14)

Country Link
US (1) US11453854B2 (uk)
EP (1) EP3522871B1 (uk)
JP (2) JP2019533995A (uk)
CN (1) CN109789097B (uk)
AU (1) AU2017339971B2 (uk)
BR (1) BR112019006900A2 (uk)
CA (1) CA3037544C (uk)
ES (1) ES2903260T3 (uk)
HU (1) HUE057035T2 (uk)
MX (1) MX2019003947A (uk)
PL (1) PL3522871T3 (uk)
PT (1) PT3522871T (uk)
UA (1) UA125029C2 (uk)
WO (1) WO2018067647A1 (uk)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN109370908A (zh) * 2018-11-16 2019-02-22 中农威特生物科技股份有限公司 一种鸡球虫卵囊的培养和保存液及其应用
CN111234035A (zh) * 2020-02-13 2020-06-05 北京海木集团有限公司 一种融合蛋白及一种犬弓形虫亚单位疫苗及其疫苗组合物

Family Cites Families (25)

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US3783098A (en) 1971-08-10 1974-01-01 Cornell Res Foundation Inc Highly potent,viable and stable cellfree virus preparations from cells infected with cell-associated viruses and method for obtaining the same
US3915794A (en) 1973-02-09 1975-10-28 Rit Rech Ind Therapeut Stabilizing compositions for cell-free viruses and cell-free virus preparations containing them
US4000256A (en) 1975-04-30 1976-12-28 Merck & Co., Inc. Varicella vaccine and process for its preparation
US4672037A (en) * 1983-11-03 1987-06-09 American Type Culture Collection Method of culturing freeze-dried microorganisms
US5078996A (en) 1985-08-16 1992-01-07 Immunex Corporation Activation of macrophage tumoricidal activity by granulocyte-macrophage colony stimulating factor
US5707617A (en) 1994-03-21 1998-01-13 The Regents Of The University Of California Bovine neospora isolates
US5571515A (en) 1994-04-18 1996-11-05 The Wistar Institute Of Anatomy & Biology Compositions and methods for use of IL-12 as an adjuvant
GB9505523D0 (en) * 1995-03-18 1995-05-03 Wellcome Found Lyophilization process
US6403098B1 (en) * 1996-09-26 2002-06-11 Merck & Co., Inc. Rotavirus vaccine formulations
PT841392E (pt) 1996-11-12 2004-11-30 Univ Auburn Vacina viva atenuada de neospora
US5856172A (en) * 1997-01-03 1999-01-05 Quality Technologies, Llc Preservation of microorganisms in a vial with a cap comprising an immobilized desiccant
BR9803232A (pt) 1997-08-26 2000-01-11 Pfizer Prod Inc Vaicna de neospora.
CA2306642A1 (en) * 1997-10-20 1999-04-29 Bayer Corporation Neospora vaccines
US20040131633A1 (en) 1999-04-21 2004-07-08 University Of Technology, Sydney Parasite antigens
AUPQ905600A0 (en) 2000-07-28 2000-08-24 Insearch Limited Parasites
OA12915A (en) 2002-08-26 2006-10-13 Pfizer Prod Inc Vaccine for respiratory and reproductive system infections in cattle.
US7935478B2 (en) 2004-02-02 2011-05-03 Core Dynamics Limited Biological material and methods and solutions for preservation thereof
US8793895B2 (en) 2006-02-10 2014-08-05 Praxair Technology, Inc. Lyophilization system and method
ES2326770B1 (es) 2007-07-13 2010-07-26 Universidad Complutense De Madrid Uso de un nuevo aislado de neospora caninum para el desarrollo de pruebas de diagnostico y para la fabricacion de productos para el tratamiento y prevencion de la infenccion causada por neospora.
TWI436789B (zh) 2008-01-21 2014-05-11 Intervet Int Bv 含有藥學化合物的顆粒之冷凍乾燥方法及含有此顆粒的藥學包
KR20200011604A (ko) * 2008-08-20 2020-02-03 안트로제네시스 코포레이션 개선된 세포 조성물 및 그의 제조 방법
BR112012020303A2 (pt) * 2010-02-19 2019-09-24 Cadila Pharmaceuticals Ltd "composição estável de células mortas com propriedades imunogênicas substancialmente retidas, e, processo e método de preparação da composição."
CN102511471B (zh) * 2011-12-15 2013-08-28 成都清科生物科技有限公司 一种间充质干细胞冻存液及其制备方法
CN103299986A (zh) * 2013-07-03 2013-09-18 中山大学 一种寄生原虫冻干粉及其制备方法
CA2948845C (en) * 2014-05-14 2022-05-31 Merial, Inc. Methods for freeze-drying and rehydrating biologics

Also Published As

Publication number Publication date
MX2019003947A (es) 2019-06-10
PL3522871T3 (pl) 2022-02-14
CN109789097B (zh) 2021-05-18
EP3522871B1 (en) 2021-11-17
CA3037544A1 (en) 2018-04-12
UA125029C2 (uk) 2021-12-29
JP2019533995A (ja) 2019-11-28
ES2903260T3 (es) 2022-03-31
AU2017339971B2 (en) 2023-03-02
US11453854B2 (en) 2022-09-27
EP3522871A1 (en) 2019-08-14
US20210284950A1 (en) 2021-09-16
CN109789097A (zh) 2019-05-21
WO2018067647A1 (en) 2018-04-12
AU2017339971A1 (en) 2019-04-11
BR112019006900A2 (pt) 2019-07-02
PT3522871T (pt) 2022-01-05
JP2022017261A (ja) 2022-01-25
HUE057035T2 (hu) 2022-04-28

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